In a significant development, the FDA has granted approval to Fabre-Kramer Pharmaceuticals for their extended-release gepirone hydrochloride tablets, set to be marketed as Exxua. This approval is specifically for the treatment of major depressive disorder (MDD) in adults.
Fabre-Kramer Pharmaceuticals, a privately-held company, claims that Exxua is a groundbreaking antidepressant for MDD in adults, uniquely acting through the selective agonism of 5HT1a receptors, thus modulating serotonin activity throughout the central nervous system. While the precise mechanism of action remains to be fully understood, Exxua offers a distinct approach to treating MDD.
It’s important to note that Exxua’s label includes a boxed warning regarding suicidal thoughts and behaviors, especially in children and young adults, for whom the drug is not approved. However, the drug does not carry safety precautions related to sexual dysfunction and weight gain.
CEO Stephen Kramer expressed his enthusiasm for the approval, characterizing it as a significant milestone in MDD treatment. He emphasized that Exxua offers both patients and physicians a fresh option for managing depression and enhancing overall quality of life.
To support Exxua’s innovative mode of action, Fabre-Kramer compiled data from over 5,000 patients, demonstrating the drug’s effectiveness in alleviating depressive symptoms with an acceptable side effect profile.
The most common adverse events reported were dizziness and nausea, which were typically mild and transient. Notably, sexual side effects and weight gain, commonly associated with antidepressants, were no more frequent in Exxua-treated patients than in those receiving a placebo.
The approval of Exxua marks the culmination of Fabre-Kramer’s extensive regulatory journey for this MDD treatment. The company initially filed a New Drug Application for gepirone hydrochloride in September 1999 but faced an FDA rejection in 2002.
Over the years, the antidepressant encountered various regulatory challenges, including a 2015 Psychopharmacologic Drugs Advisory Committee meeting that resulted in a 9-4 vote against Fabre-Kramer. The experts at the time found insufficient evidence to support the drug’s efficacy. However, the committee did express strong support for gepirone’s safety with an 11-2 vote.
With MDD approval now secured, Fabre-Kramer is set to expand Exxua’s applications to other psychiatric disorders, further solidifying its position in the field of mental health therapeutics.